Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome - Full Text View

Effectivity of Postpartum Dexamethasone for Women With Class I HELLP Syndrome (COHELLP)

This study is currently recruiting participants.

Verified October 2011 by Instituto Materno Infantil Prof. Fernando Figueira

First Received on July 7, 2008. Last Updated on October 17, 2011 History of Changes

Sponsor:	Instituto Materno Infantil Prof. Fernando Figueira
Information provided by (Responsible Party):	Leila Katz, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:	NCT00711841

Purpose

Corticotherapy accelerates maternal postpartum recovery in women with class I HELLP syndrome. The benefit of faster and better recovery would be observed in fewer complications, less utilization of blood products and shorter hospital stay.

Condition	Intervention	Phase
HELLP Syndrome	Drug: dexamethasone Drug: Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Postpartum Care

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:

severe maternal morbidity [ Time Frame: postpartum ] [ Designated as safety issue: No ]
42 days after delivery

Secondary Outcome Measures:

hospital stay duration [ Time Frame: postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	July 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: saline solution Placebo (saline solution), 2 mL, intravenous, every 12 hours, for 48 hours	Drug: dexamethasone Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours Drug: Placebo Saline solution, 2 mL, intravenous, every 12 hours, for 48 hours
Active Comparator: Dexamethasone Dexamethasone, 10mg (2mL), intravenous, every 12 hours, for 48 hours	Drug: dexamethasone dexamethasone, 10mg, 2 mL, intravenous solution, every 12 hours , for 48 hours

Detailed Description:

Patients with Class I HELLP Syndrome will be recruited for use os dexamethasone or placebo in the puerperium. Effects such as clinical course (blood pressure and diureses), laboratorial behaviour and complications will be compared. Duration of hospitalization will also be accessed.

Eligibility

Ages Eligible for Study:	13 Years to 49 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Postpartum women with Class I HELLP syndrome

Exclusion Criteria:

Chronic users of corticosteroids
Patients with chronic conditions affecting the laboratory parameters involved in the HELLP syndrome
Women who had received antenatal corticosteroids to treat HELLP syndrome were excluded

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711841

Contacts

Contact: Leila Katz, pHD	55 81 21224739 ext 4739	katzleila@yahoo.com.br
Contact: Melania M Amorim, pHD	55 83 88221514	melamorim@uol.com

Locations

Brazil
Instituto Materno Infantil Prof. Fernando Figueira	Recruiting
Recife, Pernambuco, Brazil, 50.070-550
Contact: Leila Katz, pHD 55 81 21224739 ext 4739 katzleila@yahoo.com.br

Sponsors and Collaborators

Instituto Materno Infantil Prof. Fernando Figueira

Investigators

Principal Investigator:

Leila Katz, pHD

IMIP

More Information

No publications provided

Responsible Party:	Leila Katz, Obstetrical ICU obstetrical coordinator; MD , PhD, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:	NCT00711841 History of Changes
Other Study ID Numbers:	IMIFernando Figueira
Study First Received:	July 7, 2008
Last Updated:	October 17, 2011
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:

HELLP syndrome
dexamethasone
postpartum period
class I HELLP syndrome

Additional relevant MeSH terms:

HELLP Syndrome
Hypertension, Pregnancy-Induced
Pregnancy Complications
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012